Data / Medical devices / China / Jiangxi Sanxin Medtec Co.,ltd.
Jiangxi Sanxin Medtec Co.,ltd.: FDA-registered device maker in Nanchang Jiangxi, China, 5 510(k) clearances
Jiangxi Sanxin Medtec Co.,ltd. is registered with the FDA (registration 3005246939) in Nanchang Jiangxi, China. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 6, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005246939
- Address
- No.999 Fushan Road, Xiaolan Economic Development, Nanchang Jiangxi, China, 330200
- Owner or operator
- Jiangxi Sanxin Medtec Co., Ltd. (10027789)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 3, 2008
- Registered through
- 2026
- Brand names listed
- Disposable Medical Face Masks, FOR SINGLE USE, I.V. Catheter, SANSIN Tubing Sets for Hemodialysi, YI XIN SAFETY SYRINGE, YI XIN STERILE SYRINGE, YIXIN SAFETY SYRINGE, YIXIN STERILE SYRINGE FOR SINGLE USE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2021 | K202796 | SANSIN Tubing Sets for Hemodialysis | FJK | Substantially Equivalent | Jiangxi Sanxin Medtec Co., Ltd. | accessdata.fda.gov |
| January 4, 2021 | K202719 | Disposable Medical Face Masks | FXX | Substantially Equivalent | Jiangxi Sanxin Medtec Co., Ltd. | accessdata.fda.gov |
| June 18, 2015 | K142797 | I.V. Catheter | FOZ | Substantially Equivalent | Jiangxi Sanxin Medtec Co., Ltd. | accessdata.fda.gov |
| September 2, 2005 | K050999 | YI XIN STERILE SYRINGE FOR SINGLE USE | FMF | Substantially Equivalent | Jiangxi Sanxin (Eversincere) Medical Devices Group | accessdata.fda.gov |
| March 8, 2005 | K042102 | YIXIN SAFETY SYRINGE | MEG | Substantially Equivalent | Jiangxi Sanxin (Eversincere) Medical Devices Group | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Antistick
- All makers of Mask, Surgical
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Updated September 6, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.